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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Trade NameDRIVER OVER-THE-WIRE, RAPID EXCHANGE, AND MULTI-EXCHANGE CORONARY STENT SYSTEMS
Classification Namestent, coronary
Generic Namecardiovascular stent
ApplicantMEDTRONIC IRELAND
PMA NumberP030009
Date Received04/10/2003
Decision Date10/01/2003
Product Code
MAF[ Registered Establishments with MAF ]
Docket Number 03M-0490
Notice Date 10/28/2003
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
Approval Order Statement 
Approval for the driver over-the-wire, rapid exchange, and multi-exchange coronary stent systems. These devices are indicated for improving coronary luminal diameter in patients with symptomatic ischemic heart disease due to discrete de novo or restenotic lesions with reference vessel diameters of 3. 0 - 4. 0 mm and <= 30 mm in length using direct stenting or pre-dilatation. Outcome beyond 270 days for this permanent implant is unknown at present.
Approval Order Approval Order
Supplements: S001 S002 S003 S004 S005 S007 
S008 S009 S013 S014 S015 S016 
S018 S019 S020 S021 S022 S023 
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S042 S043 S044 S045 S046 S047 
S048 S049 S050 S051 S052 S053 
S054 S055 S056 S057 S058 S060 
S061 S062 S063 S064 
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